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Using Virtual Reality to Control the Audio-visual Inputs During Ketamine/Esketamine Treatment (VR-KET)

Yale University logo

Yale University

Status

Invitation-only

Conditions

Depression

Treatments

Device: Virtual reality

Study type

Interventional

Funder types

Other

Identifiers

NCT06139016
2000036184
000

Details and patient eligibility

About

Investigators aim to examine the role of audiovisual inputs during treatment with ketamine/esketamine in affecting tolerability and effectiveness of treatment of depressive episodes, by providing patients with a relaxing environment using virtual reality goggles and noise cancelling headphones, and assessing whether these tools can improve the tolerability and effectiveness of treatment with ketamine/esketamine

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants must be at least 18 years old
  • Patients must have completed the acute series of treatment and weekly optimization phases of ketamine/esketamine treatment, and currently receiving continuation/maintenance treatment Written consent for the study procedures
  • Ability and willingness, in the investigator's judgement, to comply with the study procedure and study requirements.

Exclusion criteria

  • Hearing or visual impairment to the degree that would interfere with ability to see or hear VR content.
  • Difficulty in understanding spoken or written English
  • Unable to provide informed consent
  • Dementia or other cognitive disorder or intellectual disability that would impair the subject's ability to understand the study procedure (per investigator judgment)
  • Any other medical or psychiatric comorbidity that the investigator judges would put the participant at additional undue risk due to study participation or would impair subject's ability to participate in the study.
  • Was previously enrolled/randomized into the study

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Treatment group
Experimental group
Description:
This single arm will include all participants of the study, who will all receive the intervention
Treatment:
Device: Virtual reality

Trial contacts and locations

1

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Central trial contact

Mina Ansari, MD

Data sourced from clinicaltrials.gov

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